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C2N Diagnostics, Cambridge Isotope Ink Deal Aimed at Accelerating Biomarker Commercialization

NEW YORK (GenomeWeb News) – C2N Diagnostics today announced a research and supplier agreement with Cambridge Isotope Laboratories to provide C2N access to large quantities of highly enriched stable isotopes.

C2N uses the isotopes for its Stable Isotope Labeling Kinetic (SILK)-based biomarkers, which it said has the potential for use in the early detection of Alzheimer's well before clinical symptoms are evident. They also show promise as measurement tools for determining treatment response in preclinical and clinical drug studies, it said.

Under the terms of the deal, Cambridge is providing C2N an upfront payment of an undisclosed amount, commercial milestone fees, future supply guarantees of stable isotopes at "reasonable prices," and large supplies of GMP-grade stable isotope (13C6) labeled leucine (L-Leucine).

L-Leucine will be used by C2N in future clinical validation studies for its SILK-based tests, the St. Louis-based company said. Cambridge also has committed to significantly invest in its own infrastructure and manufacturing processes, C2N added.

"As we expand the use of our SILK-based biomarkers beyond research services and into clinical diagnostic applications, [Cambridge] will be an instrumental partner to help us qualify our test kits and to produce L-Leucine under GMP scaled-up conditions," C2N CEO Joel Braunstein said in a statement.

C2N was founded in late 2007 and commercializes biomarker assays and tools for preclinical drug discovery and clinical drug development, as well as the early detection and prognostic evaluation of neurodegenerative disorders. Its assay include the SILK-Aβ, SISAQ-Aβ, and SISAQ-Tau assays, which are based on stable isotope labeling and tandem mass spectrometry for measuring the kinetics and absolute quantitation of brain-derived proteins.

The company is developing products for Parkinson's disease, Huntington's disease, brain injury, schizophrenia, and amyotrophic lateral sclerosis, and other disorders, in addition to Alzheimer's, it said.